The federal Food and Drug Administration is adopting a new rule that will require warning labels on contraceptive products that contain the spermicide nonoxynol-9 but the federal agency is delaying the establishment of a similar rule on condoms containing N-9.
"It's still not sufficient," said Judy Auerbach, the deputy executive director of science and public policy for the San Francisco AIDS Foundation.
Echoed Anna Forbes, the deputy director for Global Campaign for Microbicides, "It seems to me that they are completely stalling about this."
The FDA is considering labeling requirements for N-9 condoms separately because it classifies condoms as "medical devices." The two major manufacturers of N-9 condoms, Church and Dwight, the makers of the Trojan brand, and Ansell, the maker of the LifeStyles brand, wrote to the FDA suggesting that warning consumers about N-9 condoms could be confusing and could cause fewer consumers to use condoms at all.
That objection was the major factor in causing the FDA to delay N-9 labeling rules.
Citing that objection, the FDA opted to study the issue further. The first phase of the study will be completed by February and the second phase, which will take about 17 weeks, will begin after the FDA analyzes the first study, according to FDA spokeswoman Peper Long.
A number of organizations, including the Global Campaign for Microbicides and SFAF, have called for the removal of N-9 from condoms.
In an advisory letter to the FDA last year, Fred Dillon, who was then SFAF's public policy and communications director, wrote: "... the San Francisco AIDS Foundation has joined with a broad coalition of women's health groups, HIV/AIDS organizations, state and local public health officials, and research scientists calling on manufacturers to remove N-9 from condoms and lubricants, because the small amount of N-9 they contain is dangerous if used rectally and offers no documented contraceptive benefit. While there has been progress on this front, we are disappointed that some companies continue to produce N-9 condoms. The San Francisco AIDS Foundation strongly encourages the FDA to take immediate steps to end the manufacturing or sale."
Barring manufacturers choosing to voluntarily remove N-9 from condoms, SFAF is recommending that the FDA require warning labels for condoms containing N-9.
N-9 was once promoted as a way to reduce the risk of HIV transmission after it was shown to kill the AIDS virus in laboratory studies. But subsequent studies on humans showed it had just the opposite effect because it stripped the protective cells lining the rectum and vagina, leaving the user at a greater risk of HIV transmission.
The FDA says that the rule governing contraceptive products other than condoms is being finalized following a public comment period. The agency expects the rule will take effect on June 19, 2008.
Although condoms containing N-9 will not be affected by the new rule, the N-9 contraceptive products will include the following warning: "Use a latex condom without nonoxynol-9 if you or your sex partner has HIV/AIDS, multiple sex partners, or other HIV risk factors."
In its exhaustive 2001 report on N-9, the World Health Organization found that N-9 condoms do not provide users with any additional contraceptive benefit and "should not be promoted."
N-9 was once included in lubricants that were marketed to gay men. After a series of articles appeared in the Bay Area Reporter in 2002, all three major manufacturers who were producing N-9 lube agreed to stop. Most manufacturers of N-9 condoms including the Berkeley-based Mayer Laboratories, which produces Kimono condoms, as well as the corporate giants, Durex and Johnson and Johnson, voluntarily stopped producing N-9 condoms.
Contrary to the WHO report, the manufacturers who still make N-9 condoms, Church and Dwight and Ansell, have maintained that N-9 condoms provide an additional contraceptive benefit.
In letters to the FDA last year, Church and Dwight and Ansell maintained that N-9 condoms provide an additional contraceptive benefit.
Forbes said that those corporations are making an "intuitive leap." Forbes said there is no evidence that the small amount of N-9 in condoms provides any benefit to the consumer.